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Cell Cure Neurosciences Ltd. Provides Update on its Product Development and Partnering ActivitiesFont size: A | A | A
8:45 AM ET 2/17/15 | BusinessWire
BioTime, Inc. (NYSE MKT: BTX) and its subsidiary Cell Cure Neurosciences Ltd. ("Cell Cure") today provided an update on Cell Cure's product development and partnering activities.
On February 16, 2015, Cell Cure opened the clinical trial of OpRegen(R) titled "Phase I/IIa Dose Escalation Safety and Efficacy Study of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium Cells Transplanted Subretinally in Patients with Advanced Dry-Form Age-Related Macular Degeneration with Geographic Atrophy" at Hadassah University Medical Center in Jerusalem, Israel. Patient enrollment is expected to begin shortly. OpRegen consists of animal product-free retinal pigment epithelial (RPE) cells with high purity and potency.
On October 31, 2014, the United States Food and Drug Administration (FDA) cleared Cell Cure's Investigational New Drug (IND) application to initiate the clinical trial of OpRegen in patients with the severe form of age-related macular degeneration (AMD) with geographic atrophy (GA). While treatment options exist for the treatment of the wet form of AMD, it amounts to only about 10% of the disease prevalence. There is currently no FDA-approved therapy for the dry form occurring in approximately 90% of those afflicted with AMD. Cell Cure intends to transplant OpRegen as a single dose into the subretinal space of patients' eyes in order to test the safety and efficacy of the product in this leading cause of blindness.
The Phase I/IIa clinical trial, will evaluate three different dose regimens of OpRegen. Following transplantation, the patients will be followed for 12 months at specified intervals, to evaluate the safety and tolerability of the product. Following the initial 12 month period, patients will continue to be monitored at longer intervals for an additional period of time. A secondary objective of the clinical trial will be to examine the ability of transplanted OpRegen to engraft, survive, and moderate disease progression in the patients. In addition to thorough characterization of visual function, a battery of ophthalmic imaging modalities will be used to quantify structural changes and rate of GA expansion.
Cell Cure also announced today that the option granted to Teva Pharmaceutical Industries Ltd. ("Teva") under a Research and Exclusive Option Agreement of October 7, 2010 to license-in rights to its OpRegenproduct has expired without having been exercised by Teva. Cell Cure will therefore be continuing the clinical development of OpRegen on its own and pursuing discussions with other potential strategic partners, including those that have already indicated interest in participating in development and commercialization of the product.
Cell Cure also announced that US patent No. 8,956,866 relating to a proprietary method of manufacturing RPE cells (the active ingredient of OpRegen) is expected to issue on February 17, 2015. This patent combined with other patents and patent applications in the BioTime family of companies provides significant patent protection for this novel therapeutic modality for AMD.
"The large markets currently associated with therapies for the wet form of AMD combined with the elegance of RPE replacement therapy for the larger unmet needs associated with the dry form, highlights why Cell Cure has prioritized the development of this product," said Dr. Charles Irving, CEO of Cell Cure. "We look forward to initiation of the trials and providing updates in the coming months.
